1. Sophia Osawe (BSc, AIMLS) Institute of Human Virology, Nigeria Nigerian Canadian Collaboration on AIDS Vaccines (NICCAV) Study Coordinator Discordant Couples Cohort Is Still Relevant For HIV Vaccine Studies Despite Low Transmission Rates; Canadian–Nigerian Experience Afri-Can Synchronicity Forum 17-19 Jan. 2012, Entebbe CHVI/CIDA GHRI/CHVI/CIDA/IDRC /CIHR

2. Background Discordant couples have been known to be medium risk group for HIV transmission. This group is suitable for HIV vaccine trials due to:  the natural exposure  high retention rates recorded in the past. A cohort of HIV sero-negative volunteers of discordant couples has been developed in Nigeria to record : behavioral data, risk factors, HIV incidence, STI infections, and retention rates. GHRI/CHVI/CIDA/IDR C/CIHR

3. Study flow Screening (Eligibility criteria) Consent & Enroll Eligible? Sero-discordance STOP 11 study visits (2 years FU) Complete *Counseling *Referrals (community) No Yes Medical examination and labs supporting HIV+ partners GHRI/CHVI/CIDA/IDR C/CIHR ● Behavioral data ●Medical history/exams ●Serology tests ●Safety Labs

4. Methods Laboratory: HIV negative  Serology tests  Safety Labs- CBC, LFT and KFT Clinical:  Medical History and Examinations  Referrals to appropriate clinics HIV positive partners-  CD4 counts (Partec Cyflow SL3 counter)  Viral Loads (ROCHE COBAS Taqman 96; HIV v2.0) GHRI/CHVI/CIDA/IDR C/CIHR

5. Results- Risk Factors Condom UseFemaleMaleTotal Always5770127 (40.3%) Never344781 (25.7%) Sometimes6641107 (34.0%) Total157158315 (100%) STIs # Enrolled # that reported STI in partners # tested positive for Syphilis Female157123 Male15841 Total31516 (5.1%)4 (1.3%) GHRI/CHVI/CIDA/IDR C/CIHR

6. Results- Risk factors (HIV+ partners) Gender HIV+ partners # on ARVs Mean CD4 (cells/µl) <10,000 cps/ml >10,000 – 1,638,42 7 cps/ml Female 131125467 6928 Male 114106394 7517 Total 245231 (94.3%) 450 134 (74.9%) 45 (25.1%) HIV incidence : The recorded incidence in this cohort is 0.6% GHRI/CHVI/CIDA/IDR C/CIHR

7. Conclusion 1.Despite antiretroviral treatment, sero- negative partners are still at risk of getting infected mainly due to:  Inconsistent and lack of condom use.  A high percentage of sero-positive partners still have detectable viral loads.  Prevailing STIs among HIV negative and HIV positive partners 2. Sero-discordant couple cohort remains an important natural adult model for transmission studies; and 3...presents an opportunity to test vaccines in HIV exposed adults GHRI/CHVI/CIDA/IDR C/CIHR

8. Acknowledgements This work was carried out with support from the Global Health Research Initiative (GHRI), a research funding partnership composed of the Canadian Institutes of Health Research, the Canadian International Development Agency, and the International Development Research Centre. PLASVIREC’s Research team: Counseling, Clinical, Data & Lab team All the discordant couples that volunteered for this study Dr. Pam Datong Dr. Evaezi Okpokoro Dr. Alash’le Abimiku GHRI/CHVI/CIDA/IDR C/CIHR